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Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequences. There is a pump controller that contains a housing, an air pump, an air reservoir, electrical power supply, pressure regulation, timing regulation and safety circuitry. A set of limb cuffs contains air bladders that fill and apply pressure. A tubing set delivers the air from the pump controller to the limb cuffs. The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.

Here's an analysis of the provided text regarding the ArtAssist device's acceptance criteria and studies:

Assessment of the Provided Information:

The provided document describes a 510(k) submission for a medical device (ArtAssist) that seeks substantial equivalence to a predicate device. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a legally marketed predicate. Therefore, the "acceptance criteria" discussed are primarily focused on demonstrating this equivalence rather than establishing de novo performance thresholds against a disease state or outcome.

The text does not contain information about:

• A table of acceptance criteria and reported device performance in the traditional sense of evaluating diagnostic accuracy (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set (clinical data).
• Data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Sample size for a training set.
• How ground truth for a training set was established.

This is because the submission is for a pneumatic compression device, not an AI or imaging diagnostic tool. The performance evaluation focuses on physical characteristics and safety, not on interpreting images or making diagnostic predictions.

Based on the provided text, here is what can be extracted and inferred regarding the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable / Not Provided. The study described is a laboratory-based equivalency comparison focusing on the device's physical functions (pressure and timing) and electrical characteristics, not a clinical study on a patient test set.
• Data Provenance: Laboratory data from ACI Medical, LLC.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable / Not Provided. The "ground truth" here is the physical performance and safety standards, not an expert-derived diagnosis or lesion classification. The assessment was against established technical specifications and standards (UL 60601-1, IEC 60601-1-2) and comparison to the predicate device's known performance characteristics.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. As noted above, this was not a study requiring human adjudication of clinical outcomes or images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is typically performed for diagnostic imaging devices where human interpretation is involved. The ArtAssist device is a treatment device, and its evaluation focuses on its physical operating parameters and safety.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done

• Yes, in essence. The "Performance data" section refers to "Pressure/timing graphs obtained in the laboratory," which evaluates the device's inherent function (algorithm/control mechanism) directly. There is no human-in-the-loop for the primary performance evaluation.

7. The Type of Ground Truth Used

• Engineering/Technical Specifications and Safety Standards, and Predicate Device Performance. The ground truth for this device's evaluation is primarily:
  • The expected pressure and timing profiles for pneumatic compression devices.
  • Compliance with recognized electrical safety standards (UL 60601-1).
  • Compliance with electromagnetic compatibility standards (IEC 60601-1-2).
  • The known performance characteristics of the legally marketed predicate device (ArtAssist K942530).

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. The device is a hardware pneumatic compression device, not an AI model that requires a "training set" in the machine learning sense. The "training" for the device's control mechanism would be its design and calibration processes, not a data-driven training set.

9. How the Ground Truth for the Training Set was Established

• Not Applicable / Not Provided. Similar to point 8, the concept of a "training set" and its "ground truth" is not relevant to this type of medical device submission. The device's operational parameters would have been designed and validated against engineering principles and intended physiological effects.

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